Postoperative Pain Management After Minimally Invasive Esophagectomy

Esophageal Cancer Clinical Trial

— MIEPVBEA  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02042313
• Other study ID #: 20131015A
• Status: Recruiting
• Phase: Phase 4
• First received: January 15, 2014
• Last updated: December 15, 2015
• Start date: February 2014

Study information

• Verified date: December 2015
• Source: Sun Yat-sen University
• Contact: Nai Liang Li, MD
• Phone: 886-2-28970011
• Email: lnl[@]kfsyscc.org
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Esophagectomy is a major surgical procedure often associated with significant morbidity and mortality and significant level of postoperative pain. In contrast to open esophagectomy where epidural pain control has been considered as a gold standard and could be crucial in affecting outcome the analgesic scheme for minimally invasive esophagectomy (MIE) is yet to be established. We would like to compare continuous epidural analgesia and continuous paravertebral block combined with single shot subcostal transversus abdominis plane (TAP) block in the analgesic effects, levels of cytokines, and postoperative complications in patients receiving MIE.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient has a physical status between ASA I and III

• 20 - 75 years of age

• Patient has signed an informed consent

• Without contraindication of GA, EA or PVB

Exclusion Criteria:

• ASA > III

• Inability to provide informed consent

• Bleeding disorders

• Being pregnant

• Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs),

• Allergy to amide-type local anesthetics or NSAIDs

• Infection at the thoracic paravertebral injection site

• Severe spine or chest wall deformity

• Patients with major psychosis or drug and alcohol abuse

• Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease

• Patients with physical disability that precludes complete cooperation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• continuous epidural infusion

• combined paravertebral infusion and single shot of TAP block

Locations

Country	Name	City	State
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tidal volume		postoperative day 1 to4	No
Primary	Intraoperative hypotension ( > 30% decline in the preoperative systolic/diastolic blood pressure)		during operation	Yes
Secondary	NRS pain score		postoperative day 0 to 4	No